Cuban regulatory agency checks Good Clinical Practices in the development of vaccine candidates

HAVANA, Cuba, Jul 2 (ACN) The Center for State Control of Medicines, Equipment and Medical Devices (CECMED) has inspected compliance with Good Clinical Practices throughout the development of Cuban vaccine candidates to ensure their scientific and ethical rigor.

Diadelis Remírez Figueredo, Ph.D., head researcher of the institution's Registration Department, mentioned that despite the volume of information, regulatory safety has not been compromised in the clinical trials and research that have been carried out in the country in the face of the COVID-19 pandemic.

So far, she said, the Center has evaluated the Good Clinical Practices in the trials carried out in the provinces of Havana, Granma, Santiago de Cuba and Guantanamo, as well as the intervention study carried out in those territories and the health intervention in the capital.

She pointed out that as part of this inspection they have verified the adherence to the protocols, where the methodology and ethical considerations to be followed are illustrated, in addition they have ensured the correct application of the drugs in the different clinical sites and the analysis of the samples in the laboratories.

The CECMED, said Remirez Figueredo, before starting a trial, certifies each vaccinator and follows the evolution from the moment the product arrives at the pharmacies, the evaluation of the subjects by the qualified personnel, the application of the immunogens and monitors the information in the data collection notebooks and the clinical histories so that there is traceability.

The institution even acts on the syringes because their manufacturer must be registered by the center, she insisted.

The Cuban regulatory authority also inspects the work of the Ethics Committee and of the Medicine Marketing and Distribution Company EMCOMED, which is in charge of handling, transporting and distributing the candidates.

After each evaluation, recommendations are made for the continuous improvement of the process, since the inspection of Good Clinical Practices is also part of the documentation required to grant the emergency use authorization, she pointed out.

Currently, the institution is immersed in the analysis of the dossier to issue the authorization for the vaccine candidate Abdala, developed by the Center for Genetic Engineering and Biotechnology (CIGB) and in the inspection of the production process, for which the production of the drug at the CIGB and the Aica Laboratories is being checked, with a view to guaranteeing compliance with Good Manufacturing Practices.

Soon, the Finlay Vaccine Institute is expected to submit the documentation to also opt for this possibility with the vaccine candidate Soberana 02.